社区参与式研究中的全方位人类受试者保护。
360 Degrees of human subjects protections in community-engaged research.
机构信息
Department of Pediatrics and MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, IL 60637, USA.
出版信息
Sci Transl Med. 2010 Aug 18;2(45):45cm23. doi: 10.1126/scitranslmed.3001162.
With the introduction of the new National Institutes of Health Roadmap in 2003, there has been a growing emphasis on translational research. Translational research challenges current human subjects protections guidelines that were written in the 1970s and were focused on the protection of the individual participant in a clinical drug trial. Community engagement requires a critical examination of the range of risks that may arise when communities are both participants and partners in research, in order to promote appropriate and effective protection of human subjects as individuals and members of communities. Given that the principal investigator has ultimate responsibility for ensuring the ethical integrity of the research, researchers should be aware of the human subjects protections delineated in the federal regulations that must be fulfilled and the other entities that can help ensure human subjects protections.
2003 年，随着新的美国国立卫生研究院路线图的引入，对转化研究的重视程度不断提高。转化研究对 20 世纪 70 年代制定的现行人类受试者保护指南提出了挑战，这些指南侧重于保护临床药物试验中的个体参与者。社区参与需要对社区在研究中既是参与者又是合作伙伴时可能出现的各种风险进行批判性审查，以促进对人类受试者作为个人和社区成员的适当和有效保护。鉴于主要研究者对确保研究的伦理完整性负有最终责任，研究人员应该了解联邦法规中规定的必须遵守的人类受试者保护以及其他可以帮助确保人类受试者保护的实体。
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